Expert Review of Medical Devices最新文献

Introduction: Favorable midterm outcomes have been reported with the use of low-profile endografts (LPE), but long-term data is still needed. Furthermore, it is unclear if each of these LPE may have advantages over the other, which may, in turn, affect the outcomes. We systematically reviewed the literature about complications and reintervention rates of patients submitted to endovascular aneurysm repair (EVAR) of abdominal aortic aneurysm (AAA) using LPE.

Matherials and methods: A literature search was conducted including articles that reported 30-days and follow-up mortality, complications, and reintervention rates of patients treated with EVAR using Incraft (Cordis), Zenith LP/Alpha (Cook Medical Inc) and Ovation (Endologix) endografts.

Results: 36 papers were evaluated, reporting results of 582 patients treated with Zenith device, 1211 with Incraft and 3449 with Ovation. During follow up, similar survival and freedom from reintervention rates were reported among the various types of endograft both at 1 and 3 years. The incidence of limb stenosis/kinking was significantly higher in patients treated with Zenith LP/Alpha (2.1%, P = 0.008), while the Incraft device had a significantly lower proportion of type III endoleaks (P < 0.001).

Conclusions: Long-term survival and freedom from reintervention rates were comparable among the three LPEs. The Cook Zenith device had the highest rates of limb stenosis/kinking, while the Incraft device had the lowest occurrence of type III endoleak.

Prospero: Registration number: CRD42022315875.

Introduction: A bone scan (BS) plays a pivotal role in many oncological and non-oncological conditions. The planar BS is characterized by high sensitivity but low specificity. With respect to planar imaging, the implementation of single-photon emission computed tomography (SPECT) has allowed increased image contrast and more accurate tracer localization.

Areas covered: Recent technological innovations in the field of BS are treated, with a particular focus on multi-field-of-view devices allowing to cover the entire scan length with a 3D acquisition (WB-SPECT/CT). In addition, the applications of cadmium zinc telluride/CzT detectors capable of converting gamma photons directly into electrical impulses (i.e. 'digital SPECT') are discussed.

Expert opinion: Initial clinical experiences indicate that WB-SPECT/CT is characterized by higher sensitivity, diagnostic accuracy, and increased confidence in image interpretation with respect to the 'old-fashioned' BS (planar images with or without a single field-of-view SPECT). Furthermore, CzT-based detectors, thanks to their superior sensitivity, might be helpful to implement fast acquisition protocols. Further studies are needed to better define the clinical impact of bone CzT WB-SPECT/CT on patients' management and outcome, as well as its cost-benefit ratio.

Introduction: Many patients listed for transplant require temporary or durable mechanical circulatory support (MCS) devices for bridging to cardiac transplantation. The choice of device for bridging to heart depends on a number of factors including level of support desired and patient-device hemocompatibility.

Areas covered: The authors summarize the current heart transplant landscape including the new UNOS listing criteria as well as indications for bridging to transplant with MCS devices. The authors also review the characteristics of commonly used MCS devices and discuss the limited evidence supporting their use in cardiogenic shock and specifically as a bridge to heart transplant.

Expert opinion: The new UNOS heart organ allocation policy has resulted in a growth in the use of temporary MCS devices as bridge to transplantation for patients with cardiogenic shock, while bridging with durable MCS devices has become more challenging. Patients supported on temporary MCS devices should be routinely assessed for potential of myocardial recovery prior to urgent transplantation. Emerging machine learning algorithms may help better identify individuals who are likely to recover on temporary or durable MCS therapy. Modifications to the current heart allocation policy may facilitate bridging of patients with durable left ventricular assist devices.

Introduction: Peritoneal dialysis (PD) is a widely used dialysis modality, which offers the advantage of being a home therapy but is associated with a risk of potentially serious infections, including exit site infection, catheter tunnel infection, and peritonitis that may result in morbidity, technique failure, and increased mortality. Catheters impregnated with antimicrobials hold promise as a novel technique to reduce PD associated infections.

Areas covered: We describe PD modalities, catheters, technique, complications, and the microbiology of associated infections, as well as standard measures to reduce the risk of infection. A novel technique for the impregnation of silicone devices with antimicrobial agents has been used to produce antimicrobial impregnated ventricular shunt catheters with proven clinical efficacy that have now been adopted as the standard of care to reduce neurosurgical infections. Using the same technology, we have developed PD and urinary catheters impregnated with sparfloxacin, triclosan, and rifampicin. Safety and tolerability have been demonstrated in urinary catheters, and a similar study is planned in PD catheters.

Expert opinion: Catheters impregnated with antimicrobials offer a simple technique to reduce PD associated infections and thereby enable more people to enjoy the advantages of PD. Clinical trials are needed to establish efficacy.

Introduction: Artificial intelligence (AI) encompasses a wide range of algorithms with risks when used to support decisions about diagnosis or treatment, so professional and regulatory bodies are recommending how they should be managed.

Areas covered: AI systems may qualify as standalone medical device software (MDSW) or be embedded within a medical device. Within the European Union (EU) AI software must undergo a conformity assessment procedure to be approved as a medical device. The draft EU Regulation on AI proposes rules that will apply across industry sectors, while for devices the Medical Device Regulation also applies. In the CORE-MD project (Coordinating Research and Evidence for Medical Devices), we have surveyed definitions and summarize initiatives made by professional consensus groups, regulators, and standardization bodies.

Expert opinion: The level of clinical evidence required should be determined according to each application and to legal and methodological factors that contribute to risk, including accountability, transparency, and interpretability. EU guidance for MDSW based on international recommendations does not yet describe the clinical evidence needed for medical AI software. Regulators, notified bodies, manufacturers, clinicians and patients would all benefit from common standards for the clinical evaluation of high-risk AI applications and transparency of their evidence and performance.

Introduction: Migraine is a prevalent, inherited and disabling brain disease with multiple symptoms and a variety of treatment options. Nerivio, utilizing remote electrical neuromodulation (REN) a wearable device, offers users good efficacy, tolerability and safety. It is user-friendly, affordable, non-addictive and cleared by the FDA and the European Conformity.

Areas covered: The device structure, mechanism of action, indications for use, application instructions, efficacy, adverse events, tolerability, safety, patient satisfaction, associated application and the research highlights are discussed herein.

Expert opinion: The device works well for most people living with migraine, often without concomitant medication, is tolerable, safe and causes minimal and mild adverse effects. It expands our migraine treatment options and improves patient adherence to treatment. Nerivio is easy-to-use and can be worn at any time of the day; it provides a non-pharmacologic option for the optimization of migraine treatment without significant adverse events.

Atrial fibrillation is the most common arrythmia and it is linked to an increased risk of stroke. Even if anticoagulation therapy reduces the rate of stroke the benefits of this therapy have to be balanced with the increased risk of hemorrhagic event. Left atrial appendage closure is a valid alternative to long-term anticoagulation in patients with atrial fibrillation and high hemorrhagic risk. Actually new devices with different features have been tested and introduced progressively in the clinical practice. Improvements in preprocedural imaging evaluation and the learning curve of the operators led to percutaneous left atrial appendage closure a safe and effective procedure. A good knowledge of different devices and the technique of implant is necessary for optimization percutaneous left atrial appendage closure and the reduction of complications during the acute phase and follow up.

Introduction: The application of robotic navigation during spine surgery has advanced rapidly over the past two decades, especially in the last 5 years. Robotic systems in spine surgery may offer potential advantages for both patients and surgeons. This article serves as an update to our previous review and explores the current status of spine surgery robots in clinical settings.

Areas covered: We evaluated the literature published from 2020 to 2022 on the outcomes of robotics-assisted spine surgery, including accuracy and its influencing factors, radiation exposure, and follow-up results.

Expert opinion: The application of robotics in spine surgery has driven spine surgery into a new era of precision treatment through a form of artificial intelligence assistance that compensates for the limitations of human abilities. Modularized robot configurations, intelligent alignment and planning incorporating multimodal images, efficient and simple human - machine interaction, accurate surgical status monitoring, and safe control strategies are the main technical features for the development of orthopedic surgical robots. The use of robotics-assisted decompression, osteotomies, and decision-making warrants further study. Future investigations should focus on patients' needs while continuing to explore in-depth medical - industrial collaborative development innovations that improve the overall utilization of artificial intelligence and sophistication in disease treatment.

Introduction and objective: Cardiac resynchronization may treat severe heart failure (HF) with pharmacological optimization, left branch block, and an ejection fraction<35%. However, 30-40% of patients fail therapy. HBP could replace biventricular pacing (BiV). We compared the effectiveness of HBP versus BiV in HF patients.

Methods: We searched PubMed, Embase, and Cochrane for studies on QRS, left ventricular ejection fraction (LVEF), New York Heart Association (NYHA) functional class, left ventricular end-systolic volume (LVESV), and 6-minute walk test.

Results: Six publications included 774 patients (mean [± standard deviation] age: 66.9 [14.0] years; 484 (62.5%) were males; 408 [52.71%] underwent HBP; the mean follow-up was 6-12 months. The HBP group had a higher QRS reduction in the meta-analysis (median: -17.54 [-20.46, -14.62]; I² = 89%). LVEF showed a median of 8.48 (7.55, 9.41) and I² of 98%, with a higher mean in HBP. The LVESV median was -18.89 (-30.03, -7.75) and I² was 0%, and the HBP group had a lower mean. HBP had a lower NYHA functional class (median= -0.20 [-0.28, -0.12]).

Conclusion: After implantation, HBP demonstrated bigger QRS shortening, increased LVEF, lower LVES volume, and lower NYHA class than BiV pacing.

Background: A new keratometric routine that employs power vector management for manual keratometers is described. This study evaluates the agreement of the new proposed keratometric technique with the classical one.

Research design and methods: The applicability of a new keratometric routine was verified using Helmholtz's and Javal's keratometers. Results were obtained by two different and well-trained examiners over two different samples, one including 65 and the other 74 eyes, respectively. Both conventional keratometry and the newly proposed routine (named vecto-keratometry) were used in each eye to obtain the results. The clinical agreement between the methods was evaluated using Bland-Altman and Passing-Bablok analysis.

Results: For Helmholtz's keratometer, Bland-Altman plots showed good agreement between methods for both astigmatic components being J₀ = 0.04 ± 0.20 D and J₄₅ = -0.07 ± 0.17 D. For Javal's keratometer, Passing-Bablok regression test determined regression line for J₀ difference as y₀ = 1.03, confidence interval: [0.98, 1.10] and regression line for J₄₅ difference as y₄₅ = 0.97, confidence interval: [0.83, 1.12].

Conclusions: Vecto-keratometry provides accurate clinical results. It has been demonstrated that there are no significant differences between methods in any of the power vector astigmatic components; thus, both methods can be applied interchangeably.